Screening devices and methods for obstructive sleep apnea therapy

Abstract

Devices and methods for treating obstructive sleep apnea by first performing an assessment of the patient that involves observing the patient's upper airway during a tongue protrusion maneuver. The assessment may, for example, be done using endoscopy to observe the upper airway while the patient is awake in the supine position. An adequate response of the upper airway during the tongue protrusion maneuver is indicative of likely therapeutic success with hypoglossal nerve stimulation, and may be used for making clinical decisions. The principles of the present invention may be applied to other therapeutic interventions for OSA involving the upper airway.

1. A method of providing therapy to a patient, comprising:
 performing an assessment of the patient, wherein the assessment comprises protruding the patient's tongue without electrical stimulation of a nerve of the patient, wherein the tongue protrusion is volitional, and observing a response of the patient's upper airway; and 
 implanting a hypoglossal nerve stimulation device in the patient only if the response comprises an increase in airway size. 
 
     
     
       2. A method as in  claim 1 , wherein the upper airway is observed while the patient is awake and supine. 
     
     
       3. A method as in  claim 1 , wherein the upper airway is observed by endoscopy. 
     
     
       4. A method as in  claim 3 , wherein the increase in airway size is at least one of retro-glossal and retro-palatal. 
     
     
       5. A method as in  claim 3 , wherein the increase in airway size comprises increase in one of an anterior-posterior dimension and a lateral dimension. 
     
     
       6. A method as in  claim 1 , wherein the assessment further comprises determining a level of collapse in the patient's upper airway. 
     
     
       7. A method as in  claim 1 , wherein the patient is treated with the therapy only if the response of the upper airway is an increase in size, and only if another response is observed during tongue protrusion. 
     
     
       8. A method of providing therapy to a patient, comprising:
 performing a tongue protrusion maneuver without electrical stimulation of a nerve of the patient, wherein the tongue protrusion is volitional, and observing a response of the patient's upper airway; and 
 treating the patient's upper airway with a therapy as a function of the observed response. 
 
     
     
       9. A method as in  claim 8 , wherein the therapy comprises a treatment for obstructive sleep apnea. 
     
     
       10. A method as in  claim 9 , wherein the therapy comprises a surgical procedure modifying tissue of the upper airway. 
     
     
       11. A method as in  claim 9 , wherein the therapy comprises implanting a device in the upper airway. 
     
     
       12. A method as in  claim 9 , wherein the upper airway is observed while the patient is awake and supine. 
     
     
       13. A method as in  claim 12 , wherein the upper airway is observed by endoscopy. 
     
     
       14. A method as in  claim 13 , wherein the increase in airway size is at least one of retro-glossal and retro-palatal. 
     
     
       15. A method as in  claim 13 , wherein the increase in airway size comprises an increase in one of an anterior-posterior dimension and a lateral dimension. 
     
     
       16. A method as in  claim 8 , wherein the assessment further comprises determining the level of collapse in the patient's upper airway. 
     
     
       17. A method of providing therapy to a patient, comprising:
 performing a palatoglossal arch maneuver and observing a response of the patient's upper airway, wherein the palatoglossal arch maneuver includes volitional tongue protrusion in the absence of electrical stimulation; and 
 treating the patient's upper airway with a therapy as a function of the observed response. 
 
     
     
       18. A method as in  claim 17 , wherein the upper airway is observed while the patient is awake and supine. 
     
     
       19. A method as in  claim 18 , wherein the upper airway is observed by endoscopy. 
     
     
       20. A method as in  claim 19 , wherein the increase in airway size is at least one of retro-glossal and retro-palatal. 
     
     
       21. A method as in  claim 19 , wherein the increase in airway size comprises an increase in one of an anterior-posterior dimension and a lateral.